A study to assess the safety, tolerability, and single dose pharmacokinetics of a marketed drug in pediatric subjects with migraines.

After completion of a portion of the study (Panels A and B), a regulatory agency issued an amended request that the 12-17 year old age group studied should include a similar number of male and female subjects. Therefore, the study was amended to add an additional panel of subjects (Panel C) to ensure gender balance specifically in this age group.

Subjects allocated to Panel A and randomized to receive a single dose of rizatriptan 5 mg orally disintegrating tablet (ODT) on Day 1.

Subjects weighing 20-39 kg were allocated to Panel A.

Drug: rizatriptan benzoate (5 mg)

A single dose of rizatriptan 5 mg administered on Day 1.

Other Names:

MAXALT®

MK0462

Placebo Comparator: Panel A Placebo

Subjects allocated to Panel A and randomized to receive a single dose of rizatriptan 5 mg orally disintegrating tablet (ODT) placebo on Day 1.

Subjects weighing 20-39 kg were allocated to Panel A.

Drug: Rizatriptan 5 mg Placebo

A single dose of rizatriptan 5 mg placebo administered on Day 1.

Experimental: Panel B Rizatriptan

Subjects allocated to Panel B and randomized to receive a single dose of rizatriptan 10 mg orally disintegrating tablet (ODT) on Day 1.

Subjects weighing 40 kg and above were allocated to Panel B.

Drug: rizatriptan benzoate (10 mg)

A single dose of rizatriptan 10 mg administered on Day 1.

Other Names:

MAXALT®

MK0462

Placebo Comparator: Panel B Placebo

Subjects allocated to Panel B and randomized to receive a single dose of rizatriptan 10 mg orally disintegrating tablet (ODT) placebo on Day 1.

Subjects weighing 40 kg and above were allocated to Panel B.

Drug: Rizatriptan 10 mg Placebo

A single dose of rizatriptan 10 mg placebo administered on Day 1.

Experimental: Panel C Rizatriptan

Subjects allocated to Panel C and randomized to receive a single dose of rizatriptan ODT on Day 1. Subjects in Panel C weighing 20-39 kg received a 5 mg dose and subjects weighing 40 kg and above received a 10 mg dose.

Panel C was added to the study by amendment to increase the number of male subjects in the 12-17 year old age group.

Drug: rizatriptan benzoate (5 mg)

A single dose of rizatriptan 5 mg administered on Day 1.

Other Names:

MAXALT®

MK0462

Drug: rizatriptan benzoate (10 mg)

A single dose of rizatriptan 10 mg administered on Day 1.

Other Names:

MAXALT®

MK0462

Placebo Comparator: Panel C Placebo

Subjects allocated to Panel C and randomized to receive a single dose of rizatriptan ODT placebo on Day 1. Subjects in Panel C weighing 20-39 kg received a 5 mg placebo dose and subjects weighing 40 kg and above received a 10 mg placebo dose.

Panel C was added to the study by amendment to increase the number of male subjects in the 12-17 year old age group.

Drug: Rizatriptan 5 mg Placebo

A single dose of rizatriptan 5 mg placebo administered on Day 1.

Drug: Rizatriptan 10 mg Placebo

A single dose of rizatriptan 10 mg placebo administered on Day 1.

Eligibility

Ages Eligible for Study:

6 Years to 17 Years

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Panel A and B: Male and female subjects (non-smokers) ages 6 to 17 with a history of migraines

Panel C: Male subjects (non-smokers) ages 12 to 17 with a history of migraines

Subject has a history of migraine headaches, and is not experiencing a migraine on the day of study drug administration

Subject has a condition which, in the opinion of the investigator, may interfere with optimal participation in the study

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.